Chronic Obstructive Pulmonary DiseaseNCT04448236
Effect of Blood Flow Restriction Resistance Exercises in COPDAE In-patient Rehabilitation
A study testing Blood flow restriction resistance exercise in people with Chronic Obstructive Pulmonary Disease and Acute Exacerbation of COPD, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
Trial summary
This is a randomised controlled trial of the blood flow restriction resistance exercise (BFR-RE) for early rehabilitation of chronic obstructive pulmonary disease acute exacerbation (COPDAE) in the Haven of Hope Hospital. BFR-RE was invented by Dr. Yoshiaki Sato in Japan 40 years ago. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Acute Exacerbation of COPD
- What is being tested?
- Blood flow restriction resistance exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteHong Kong
- Study dates
- 10 Jun 2020to 9 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD acute exacerbation (COPDAE) as the primary diagnosis for hospitalization or transfer to pulmonary wards of the Haven of Hope Hospital
- Able to walk under supervision
- Understand instruction in Cantonese and can give informed consent.
Who cannot join
- Concomitant acute cardiac event
- Severe hypertension (BP > 180/100)
- History of venous thromboembolism
- History of peripheral vascular disease
- Absence of posterior tibial or dorsalis pedal pulse
- History of revascularization of the extremity
Show all 15Show fewer
- History of lymphectomies
- Extremities with dialysis access
- Vascular grafting
- Current extremity infection
- Active malignancy
- Open fracture / soft tissue injuries
- Amputation to the lower extremity
- Expected hospitalization less than 2 weeks on admission
- Medications known to increase clotting risks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects on Muscle Strength After Blood Flow Restriction Resistance Exercise (BFR-RE) in Early In-patient Rehabilitation of Chronic Obstructive Pulmonary Disease Acute Exacerbation (COPDAE), a Single Blinded, Randomized Controlled Study
This is a randomised controlled trial of the blood flow restriction resistance exercise (BFR-RE) for early rehabilitation of chronic obstructive pulmonary disease acute exacerbation (COPDAE) in the Haven of Hope Hospital.
BFR-RE was invented by Dr. Yoshiaki Sato in Japan 40 years ago. This exercise was newly introduced to the Physiotherapy Department of Haven of Hope Hospital in March, 2020 and not a routine common training in Hospital Authority. However, currently the "BFR-device" is in its 3rd generation. Under the guidance of a certified physiotherapist, a "low load intensity" can be used for resistance training to build up muscle mass and strength by applying the device over the thigh to partially limit the blood flow to the distal limb.
Read more
BFR-RE is well studied in athletes, elderlies and patients for rehabilitation after orthopaedics surgeries. A large amount of literature reveals BFR-RE with "low load intensity" shows comparable increase of muscle mass as "high load intensity" resistance training and more increase of muscle strength than those only undergoing "low load intensity" resistance training.
The objective of this study is to investigate the additional effects of 2-week BFR-RE in patients with COPDAE on top of the conventional in-patient rehabilitation training. The primary outcome is effect on localized muscle strength. The secondary outcomes include mobility function, systemic muscle strength as reflected by handgrip strength(HGS), health related quality of life, unplanned readmission to acute hospital rate within 1 month for COPDAE.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a prevalent disease around the world particularly in developed countries. COPD often has frequent admissions for acute exacerbation which increase the risks of mortality. Muscular dysfunction is one of extra-pulmonary morbidity of COPD.
Reduced muscle strength is associated with increased mortality in moderate to severe COPD. However, at least 70% of 1-repetition maximum (1-RM) of weight is needed to achieve muscle growth in resistance training. This might not be feasible particularly to the patients admitted for COPD acute exacerbation (COPDAE).
Blood flow restriction resistance training (BFR-RE), Kaatsu training, was developed by Dr. Yoshiaki Sato more than 40 years ago. The basic physiological mechanism of BFR-RE to increase muscle mass and strength is by metabolite accumulation, e.g. lactate. The metabolites lead to increase of serum growth hormone (GH) which promotes the collagen synthesis for tissue repair and recovery. The surge of GH leads to release of insulin-like growth factor (IGF-1) which is a protein related to muscle growth. IGF-1 contributes the muscle gain, which is a muscular anabolic process, by enhancing satellite cell proliferation.
Concerning growth of muscle mass, BFR-RE leads to a comparable increase when compared to high load resistance exercise (HL-RE). However, concerning increase of muscle strength, BFR-RE is less effective in gain than that in HL- RE but more effective than that in low load resistance exercise (LL-RE) alone. Therefore, BFR-RE can be considered when HL- RE is not advisable. (e.g. frail elderly, post-operative rehabilitation, etc.) BFR-RE is well studied among healthy adult, elderly and musculoskeletal rehabilitation patients, but not in COPDAE patients.
Standardized isotonic knee extension resistance training on alternate day with a load of 15-30% of 1-Repetition Maximum (1-RM) with "BFR-device" will be compared with the control arm having same set of exercise training without the device in COPDAE patient during 2-week of inpatient stay. Referred to previous study with 30% drop out rate estimation, 24 patients for each arm will be needed. Study period will be set to be 9 months or until expected recruitment achieved.
Though there no adverse risk responses were reported in published randomized controlled trials in clinical populations in the literature, there are some expected transient perceptual type responses, e.g. dizziness, limb numbness, perceived exertion, delayed onset muscle soreness. There are no significant risks of complications if BFR-RE is prescribed by certified trainers who have knowledge of appropriate protocols and contraindications to the use of occlusive stimuli.
The effect on muscle strength in COPDAE inpatient, which is not well studied in the literatures, will be the primary outcome of this study. The effect on mobility functions, systemic muscle strength, health related quality of life, unplanned readmission rate within 1 month of discharge for COPDAE, acceptability and feasibility of the BFR-RE will be evaluated as secondary outcomes.
- Being tested
- Blood flow restriction resistance exercise
- Keywords
- muscle strength, COPDAE, BFRRE, isometric knee extension
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction resistance exerciseDevice
Application the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension
| Study group | Role | What they receive |
|---|---|---|
| BFR-RE intervention group | Experimental | The participants will have the standardised 2 week resistance training with "BFR-device" with details as follows:
* Cuff size: medium
* Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists)
* Applied location: alternate quadriceps in consecutive day
* Applied pressure: 80% limb occlusion pressure (LOP) Receives: Device: Blood flow restriction resistance exercise |
| Control group | No intervention | Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Maximal Voluntary Isometric Contraction (MVIC) of Knee Extension of the Dominant Leg in 3 Weeks
To measure the change of the force-producing capabilities of a muscle group objectively during its isometric contraction condition which means muscle group under contraction with a constant velocity of joint motion and muscle length.
Computer dynamometer will be used to measure the MVIC of the isometric knee extension of the dominant leg.
Measured: baseline and 3 weeks (after 10-12 sessions of training)
Secondary outcomes (9)
Change of Scores of Short Physical Performance Battery (SPPB) in 3 Weeks
SPPB is the sum of the points from the following 3 measures, high the point, better performance
- Time needed to walk 4m distance: less than 4.82s=4 points, 4.82-6.2s=3 points, 6.21-8.7s=2 points, >8.7s=1 point; if unable to do the walk=0 point
- Balance test: can hold side by side stand 10s= 1 point; semi-tandem stand 10s=1 point; tandem stand 10s=2 point; tandem stand 3-9.99s=1 point; if unable to do the stand=0 point
- Repeated chair stands test:; Participant unable to complete 5 chair stands or completes stands in >60s =0 point; If chair stand time is 16.70s or more= 1 point; If chair stand time is 13.70 to 16.69s = 2 points; If chair stand time is 11.20 to 13.69s=3 points; If chair stand time is 11.19s or less= 4 points
Minimum score=0 Maximum score=12(best performance)
Measured: baseline and 3 weeks (after 10-12 sessions of training)
Change of Hand Grip Strength in 3 Weeks
a non-invasive marker of systemic skeletal muscle strength and function, is assessed by handheld grip dynamometer of dominant hand
Measured: baseline and 3 weeks (after 10-12 sessions of training)
Change of Health Related Quality of Life in 3 Weeks
Self-administered Chinese version of Chronic obstructive pulmonary disease(COPD) assessment test (CAT) It contains 8 questions and 6 points each (0 to 5). Higher score means worse health status. The Minimal clinical important difference of CAT score was 2 to 3.
Minimum score=0 Maximum score=40 (worst health status)
Measured: baseline and 3 weeks (after 10-12 sessions of training)
Average Pain Score of Each Training
Visual analog scale (0-10) for before, immediate and 5-minute post exercise. least pain=0 ; most severe pain=10
Measured: pain score before, immediate and 5-minute post exercise;
Reasons of Drop-out of Blood Flow Restriction Resistance Exercise
Examination the reasons of drop-out in those discontinuing the training
Measured: baseline to 3 weeks (after 10-12 sessions of training)
Feasibility of BFR Exercise
Examination of drop-out rate
Measured: baseline and 3 weeks (after 10-12 sessions of training)
Unplanned Readmission Rate on 1 Month Post Discharge
Unplanned readmission rate within 1 month of discharge for Chronic Obstructive Pulmonary Disease Acute Exacerbation (COPDAE)
Measured: 1 month after the discharge of patients in the study
6-minute Walk Test Distance Gain
the distance can achieved in 6-minute walk test
Measured: baseline and 3 weeks (after 10-12 sessions of training)
Acceptability of Blood Flow Restriction Resistance Exercise
Measure the patient's acceptance by a 5-point categorical scale after the whole program.
1=very dislike, 2=dislike,3=no comment, 4= like, 5=very like Lowest score=1 Highest score=5(Higher score means better acceptance)
Measured: Acceptance scale will be assessed immediately after the program after 3 (after 10-12 sessions of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start10 Jun 2020
- Primary completion9 Dec 2020
- Study completion9 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized into one of the two treatment groups by drawing enclosed envelops which contain the random allocation of participants to intervention group (training with "BFR-device" and control group (training without the device). The envelopes are opened after inclusion for the individual participant only. Stratification of participants into two groups by maximum voluntary isometric contraction (MVIC) at baseline before randomization will be done. The cutoff for the stratification will be determined from the data in the recent service.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Authority, Hong Kong
- Sponsor type
- Other government
- Responsible party
- Principal investigator, LAU chung wai, Hospital Authority, Hong Kong
- Investigators
- chung wai LAU, MBBS, Principal investigator, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448236
- Sponsor's protocol ID
- BFR-RE in COPDAE
- Status last verified
- Jan 2024
- First submitted
- 13 Jun 2020
- Last updated
- 17 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
PubMed 19204579Brandner, C. R., May, A. K., Clarkson, M. J., & Warmington, S. A. Reported Side-effects and Safety Considerations for the Use of Blood Flow Restriction During Exercise in Practice and Research. Techniques in Orthopaedics. 2018; 33(2), 114-121.
Centner C, Wiegel P, Gollhofer A, Konig D. Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):95-108. doi: 10.1007/s40279-018-0994-1.
PubMed 30306467Cook SB, LaRoche DP, Villa MR, Barile H, Manini TM. Blood flow restricted resistance training in older adults at risk of mobility limitations. Exp Gerontol. 2017 Dec 1;99:138-145. doi: 10.1016/j.exger.2017.10.004. Epub 2017 Oct 5.
PubMed 28987643Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
PubMed 28259850Manini TM, Clark BC. Blood flow restricted exercise and skeletal muscle health. Exerc Sport Sci Rev. 2009 Apr;37(2):78-85. doi: 10.1097/JES.0b013e31819c2e5c.
PubMed 19305199Sato, Y. The history and future of KAATSU Training. International Journal of KAATSU Training Research. 2005; 1(1): 1-5.
Swallow EB, Reyes D, Hopkinson NS, Man WD, Porcher R, Cetti EJ, Moore AJ, Moxham J, Polkey MI. Quadriceps strength predicts mortality in patients with moderate to severe chronic obstructive pulmonary disease. Thorax. 2007 Feb;62(2):115-20. doi: 10.1136/thx.2006.062026. Epub 2006 Nov 7.
PubMed 17090575Van't Hul A, Harlaar J, Gosselink R, Hollander P, Postmus P, Kwakkel G. Quadriceps muscle endurance in patients with chronic obstructive pulmonary disease. Muscle Nerve. 2004 Feb;29(2):267-74. doi: 10.1002/mus.10552.
PubMed 14755493Kroemer KH, Marras WS. Towards an objective assessment of the "maximal voluntary contraction" component in routine muscle strength measurements. Eur J Appl Physiol Occup Physiol. 1980;45(1):1-9. doi: 10.1007/BF00421195.
PubMed 7191799Robles PG, Mathur S, Janaudis-Fereira T, Dolmage TE, Goldstein RS, Brooks D. Measurement of peripheral muscle strength in individuals with chronic obstructive pulmonary disease: a systematic review. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):11-24. doi: 10.1097/HCR.0b013e3181ebf302.
PubMed 20724932Bernabeu-Mora R, Medina-Mirapeix F, Llamazares-Herran E, Garcia-Guillamon G, Gimenez-Gimenez LM, Sanchez-Nieto JM. The Short Physical Performance Battery is a discriminative tool for identifying patients with COPD at risk of disability. Int J Chron Obstruct Pulmon Dis. 2015 Dec 3;10:2619-26. doi: 10.2147/COPD.S94377. eCollection 2015.
PubMed 26664110Hicks RW, Denholm B. Implementing AORN recommended practices for care of patients undergoing pneumatic tourniquet-assisted procedures. AORN J. 2013 Oct;98(4):383-93; quiz 394-6. doi: 10.1016/j.aorn.2013.08.004.
PubMed 24075334Kearon C, Ageno W, Cannegieter SC, Cosmi B, Geersing GJ, Kyrle PA; Subcommittees on Control of Anticoagulation, and Predictive and Diagnostic Variables in Thrombotic Disease. Categorization of patients as having provoked or unprovoked venous thromboembolism: guidance from the SSC of ISTH. J Thromb Haemost. 2016 Jul;14(7):1480-3. doi: 10.1111/jth.13336. Epub 2016 Jun 7. No abstract available.
PubMed 27428935Jeong M, Kang HK, Song P, Park HK, Jung H, Lee SS, Koo HK. Hand grip strength in patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2017 Aug 9;12:2385-2390. doi: 10.2147/COPD.S140915. eCollection 2017.
PubMed 28848339
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects on Muscle Strength After Blood Flow Restriction Resistance Exercise (BFR-RE) in Early In-patient Rehabilitation of Chronic Obstructive Pulmonary Disease Acute Exacerbation (COPDAE), a Single Blinded, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04448236
- Acronym / sponsor ID
- BFR-RE in COPDAE
- Keywords
- muscle strength, COPDAE, BFRRE, isometric knee extension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Hospital Authority, Hong KongOther government
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 9 Dec 2020 (actual)
- Study completion
- 9 Dec 2020 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Posted 17 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomised controlled trial of the blood flow restriction resistance exercise (BFR-RE) for early rehabilitation of chronic obstructive pulmonary disease acute exacerbation (COPDAE) in the Haven of Hope Hospital.
BFR-RE was invented by Dr. Yoshiaki Sato in Japan 40 years ago. This exercise was newly introduced to the Physiotherapy Department of Haven of Hope Hospital in March, 2020 and not a routine common training in Hospital Authority. However, currently the "BFR-device" is in its 3rd generation. Under the guidance of a certified physiotherapist, a "low load intensity" can be used for resistance training to build up muscle mass and strength by applying the device over the thigh to partially limit the blood flow to the distal limb.
BFR-RE is well studied in athletes, elderlies and patients for rehabilitation after orthopaedics surgeries. A large amount of literature reveals BFR-RE with "low load intensity" shows comparable increase of muscle mass as "high load intensity" resistance training and more increase of muscle strength than those only undergoing "low load intensity" resistance training.
The objective of this study is to investigate the additional effects of 2-week BFR-RE in patients with COPDAE on top of the conventional in-patient rehabilitation training. The primary outcome is effect on localized muscle strength. The secondary outcomes include mobility function, systemic muscle strength as reflected by handgrip strength(HGS), health related quality of life, unplanned readmission to acute hospital rate within 1 month for COPDAE.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a prevalent disease around the world particularly in developed countries. COPD often has frequent admissions for acute exacerbation which increase the risks of mortality. Muscular dysfunction is one of extra-pulmonary morbidity of COPD.
Reduced muscle strength is associated with increased mortality in moderate to severe COPD. However, at least 70% of 1-repetition maximum (1-RM) of weight is needed to achieve muscle growth in resistance training. This might not be feasible particularly to the patients admitted for COPD acute exacerbation (COPDAE).
Blood flow restriction resistance training (BFR-RE), Kaatsu training, was developed by Dr. Yoshiaki Sato more than 40 years ago. The basic physiological mechanism of BFR-RE to increase muscle mass and strength is by metabolite accumulation, e.g. lactate. The metabolites lead to increase of serum growth hormone (GH) which promotes the collagen synthesis for tissue repair and recovery. The surge of GH leads to release of insulin-like growth factor (IGF-1) which is a protein related to muscle growth. IGF-1 contributes the muscle gain, which is a muscular anabolic process, by enhancing satellite cell proliferation.
Concerning growth of muscle mass, BFR-RE leads to a comparable increase when compared to high load resistance exercise (HL-RE). However, concerning increase of muscle strength, BFR-RE is less effective in gain than that in HL- RE but more effective than that in low load resistance exercise (LL-RE) alone. Therefore, BFR-RE can be considered when HL- RE is not advisable. (e.g. frail elderly, post-operative rehabilitation, etc.) BFR-RE is well studied among healthy adult, elderly and musculoskeletal rehabilitation patients, but not in COPDAE patients.
Standardized isotonic knee extension resistance training on alternate day with a load of 15-30% of 1-Repetition Maximum (1-RM) with "BFR-device" will be compared with the control arm having same set of exercise training without the device in COPDAE patient during 2-week of inpatient stay. Referred to previous study with 30% drop out rate estimation, 24 patients for each arm will be needed. Study period will be set to be 9 months or until expected recruitment achieved.
Though there no adverse risk responses were reported in published randomized controlled trials in clinical populations in the literature, there are some expected transient perceptual type responses, e.g. dizziness, limb numbness, perceived exertion, delayed onset muscle soreness. There are no significant risks of complications if BFR-RE is prescribed by certified trainers who have knowledge of appropriate protocols and contraindications to the use of occlusive stimuli.
The effect on muscle strength in COPDAE inpatient, which is not well studied in the literatures, will be the primary outcome of this study. The effect on mobility functions, systemic muscle strength, health related quality of life, unplanned readmission rate within 1 month of discharge for COPDAE, acceptability and feasibility of the BFR-RE will be evaluated as secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized into one of the two treatment groups by drawing enclosed envelops which contain the random allocation of participants to intervention group (training with "BFR-device" and control group (training without the device). The envelopes are opened after inclusion for the individual participant only. Stratification of participants into two groups by maximum voluntary isometric contraction (MVIC) at baseline before randomization will be done. The cutoff for the stratification will be determined from the data in the recent service.
| Arm | Type | Receives |
|---|---|---|
| BFR-RE intervention group | Experimental | Device: Blood flow restriction resistance exerciseThe participants will have the standardised 2 week resistance training with "BFR-device" with details as follows: * Cuff size: medium * Restriction time: 5- 10 mins (stop after finishing 4 sets of training or terminating by Physiotherapists) * Applied location: alternate quadriceps in consecutive day * Applied pressure: 80% limb occlusion pressure (LOP) |
| Control group | No intervention | –Same standardized 2-week in-patient rehabilitation and same amount of the above-mentioned resistance training without the "BFR device". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD acute exacerbation (COPDAE) as the primary diagnosis for hospitalization or transfer to pulmonary wards of the Haven of Hope Hospital
- Able to walk under supervision
- Understand instruction in Cantonese and can give informed consent.
Key exclusion criteria (15 listed)
- Concomitant acute cardiac event
- Severe hypertension (BP > 180/100)
- History of venous thromboembolism
- History of peripheral vascular disease
- Absence of posterior tibial or dorsalis pedal pulse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction resistance exerciseApplication the "Blood flow restriction device" over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension | Device | BFR-RE intervention group |
Primary outcome
Change of Maximal Voluntary Isometric Contraction (MVIC) of Knee Extension of the Dominant Leg in 3 Weeks
Time frame: baseline and 3 weeks (after 10-12 sessions of training)
To measure the change of the force-producing capabilities of a muscle group objectively during its isometric contraction condition which means muscle group under contraction with a constant velocity of joint motion and muscle length. Computer dynamometer will be used to measure the MVIC of the isometric knee extension of the dominant leg.
9 secondary outcomes
Change of Scores of Short Physical Performance Battery (SPPB) in 3 Weeks
Time frame: baseline and 3 weeks (after 10-12 sessions of training)
Change of Hand Grip Strength in 3 Weeks
Time frame: baseline and 3 weeks (after 10-12 sessions of training)
Change of Health Related Quality of Life in 3 Weeks
Time frame: baseline and 3 weeks (after 10-12 sessions of training)
Average Pain Score of Each Training
Time frame: pain score before, immediate and 5-minute post exercise;
Reasons of Drop-out of Blood Flow Restriction Resistance Exercise
Time frame: baseline to 3 weeks (after 10-12 sessions of training)
Feasibility of BFR Exercise
Time frame: baseline and 3 weeks (after 10-12 sessions of training)
Unplanned Readmission Rate on 1 Month Post Discharge
Time frame: 1 month after the discharge of patients in the study
6-minute Walk Test Distance Gain
Time frame: baseline and 3 weeks (after 10-12 sessions of training)
Acceptability of Blood Flow Restriction Resistance Exercise
Time frame: Acceptance scale will be assessed immediately after the program after 3 (after 10-12 sessions of training)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19204579American College of Sports Medicine. American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009 Mar;41(3):687-708. doi: 10.1249/MSS.0b013e3181915670.
- BackgroundBrandner, C. R., May, A. K., Clarkson, M. J., & Warmington, S. A. Reported Side-effects and Safety Considerations for the Use of Blood Flow Restriction During Exercise in Practice and Research. Techniques in Orthopaedics. 2018; 33(2), 114-121.
- Background: PubMed 30306467Centner C, Wiegel P, Gollhofer A, Konig D. Effects of Blood Flow Restriction Training on Muscular Strength and Hypertrophy in Older Individuals: A Systematic Review and Meta-Analysis. Sports Med. 2019 Jan;49(1):95-108. doi: 10.1007/s40279-018-0994-1.
- Background: PubMed 28987643Cook SB, LaRoche DP, Villa MR, Barile H, Manini TM. Blood flow restricted resistance training in older adults at risk of mobility limitations. Exp Gerontol. 2017 Dec 1;99:138-145. doi: 10.1016/j.exger.2017.10.004. Epub 2017 Oct 5.
- Background: PubMed 28259850Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
- Background: PubMed 19305199Manini TM, Clark BC. Blood flow restricted exercise and skeletal muscle health. Exerc Sport Sci Rev. 2009 Apr;37(2):78-85. doi: 10.1097/JES.0b013e31819c2e5c.
- BackgroundSato, Y. The history and future of KAATSU Training. International Journal of KAATSU Training Research. 2005; 1(1): 1-5.
- Background: PubMed 17090575Swallow EB, Reyes D, Hopkinson NS, Man WD, Porcher R, Cetti EJ, Moore AJ, Moxham J, Polkey MI. Quadriceps strength predicts mortality in patients with moderate to severe chronic obstructive pulmonary disease. Thorax. 2007 Feb;62(2):115-20. doi: 10.1136/thx.2006.062026. Epub 2006 Nov 7.
- Background: PubMed 14755493Van't Hul A, Harlaar J, Gosselink R, Hollander P, Postmus P, Kwakkel G. Quadriceps muscle endurance in patients with chronic obstructive pulmonary disease. Muscle Nerve. 2004 Feb;29(2):267-74. doi: 10.1002/mus.10552.
- Background: PubMed 7191799Kroemer KH, Marras WS. Towards an objective assessment of the "maximal voluntary contraction" component in routine muscle strength measurements. Eur J Appl Physiol Occup Physiol. 1980;45(1):1-9. doi: 10.1007/BF00421195.
- Background: PubMed 20724932Robles PG, Mathur S, Janaudis-Fereira T, Dolmage TE, Goldstein RS, Brooks D. Measurement of peripheral muscle strength in individuals with chronic obstructive pulmonary disease: a systematic review. J Cardiopulm Rehabil Prev. 2011 Jan-Feb;31(1):11-24. doi: 10.1097/HCR.0b013e3181ebf302.
- Background: PubMed 26664110Bernabeu-Mora R, Medina-Mirapeix F, Llamazares-Herran E, Garcia-Guillamon G, Gimenez-Gimenez LM, Sanchez-Nieto JM. The Short Physical Performance Battery is a discriminative tool for identifying patients with COPD at risk of disability. Int J Chron Obstruct Pulmon Dis. 2015 Dec 3;10:2619-26. doi: 10.2147/COPD.S94377. eCollection 2015.
- Individual participant dataSharing planned: No
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Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
chung wai LAU, MBBS principal investigator
Hospital Authority, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction resistance exercise in people with Chronic Obstructive Pulmonary Disease and Acute Exacerbation of COPD, run by Hospital Authority, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Maximal Voluntary Isometric Contraction (MVIC) of Knee Extension of the Dominant Leg in 3 Weeks (time frame: baseline and 3 weeks (after 10-12 sessions of training)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448236, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.